NA BB1A19R53Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000371456), received between Jun 16, 2023 and Aug 27, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

25 other recalls cover devices cleared under the same FDA submission (K171979); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

   Z-1027-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Obstruction of Flow; Misassembled During Installation; Obstruction of Flow; Misassembled During Installation

  IT WAS REPORTED THAT DURING USE OF THE CUSTOM TUBING PACK, THE ARTERIAL BOOT WAS IDENTIFIED AS A STRAIGHT 3/8" TUBING INSTEAD OF THE REQUIRED 3/8" BY 1/2" TAPERED BOOT. LOW FLOW WAS OBSERVED. THE RPMS WERE INCREASED. A FLOW PROBE WAS ATTACHED TO THE LINE AND RPMS INCREASED TO AN APPROPRIATE FLOW. THE ISSUE WAS NOT DIAGNOSED UNTIL AFTER THEY CAME OFF BYPASS. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLOW PROBE WAS ATTACHED DUE TO THE ISSUE WITH THE CUSTOM TUBING PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902160 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THERE WAS A LEAK FROM THE DEVICE. THERE WAS NO PATIENT BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK. THE LEAK WAS LOCATED AT THE SAMPLE MANIFOLD LINE ON THE ARTERIAL SIDE NEAR THE ONE-WAY VALVE. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875342 ↗
• MalfunctionJan 19, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THE STOPCOCK WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541250 ↗
• MalfunctionNov 22, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT 3 STOPCOCKS WERE FOUND BROKEN IN THE PACK. THE CUSTOM PACK AND THE STOP COCKS WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE 3 STOP COCKS WERE PARTIALLY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18189901 ↗
• MalfunctionJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT ONE OF THE LUER PORT CAPS FROM THE PACK HAD A PIN HOLE LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180815 ↗
• MalfunctionJun 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE CUSTOM TUBING PACK THE CUSTOMER NOTICED THAT THE LUER PORT WAS LEAKING DURING PRIME. THE CAP WAS REPLACED AT PRIME AND NOT USED DURING THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EVENT OCCURRED. ADDITIONAL INFORMATION FROM THE SALES REP: THE ACCOUNT DIDN¿T MENTION WHICH CAP, ONLY THAT IS WAS A STOPCOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142100 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171979. One submission often covers many models, so check the product and lot details in each record.

• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1892-2021 · Apr 29, 2021 · Terminated
  Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
• Z-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
• Z-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
• Z-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
• Z-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
• Z-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
• Z-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
• Z-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
• Z-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
• Z-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.

…and 10 more.